Plain-English translation of NCT07119372 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing a new medication called BCD-131 to see if it can treat anemia—low red blood cell counts—as effectively as an existing medication called Mircera in people with advanced kidney disease who use dialysis. Both medications work by helping your body make more red blood cells. The study will compare how well the new medication works and whether it's safe over 32 weeks of treatment.
People with end-stage kidney disease often develop anemia because their damaged kidneys can't produce enough of a hormone that signals the body to make red blood cells. Researchers want to find out if this new medication can be an effective alternative to currently available treatments.
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You will visit the study center for a screening period (4 weeks), then enter the main treatment period (32 weeks) where you'll receive either BCD-131 or Mircera and have your blood checked regularly. The first 12 weeks involve dose adjustments, followed by 20 weeks of maintenance therapy. After that, there's an optional extension period (20 weeks) for long-term safety monitoring, and a final follow-up visit 4 weeks later. Throughout the study, you'll continue your regular dialysis sessions.
AI-generated summary from trial data · Jul 2, 2026 · Not medical advice
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